Proposal abstract

EuroGentest is an FP6 European network for the harmonization of genetic testing and for the further improvement of quality in genetic services across Europe. At a time of increase of genetic testing in Europe, whereby test samples, patients and professionals increasingly cross borders, uniform quality criteria for genetic services have become imperative.

This proposal is to support a Coordination Action, EuroGentest2, that will cover the different aspects of quality assurance of genetic practice and has all the ingredients to fulfill the needs. EuroGentest2 will be concerned with setting the targets for laboratory and health professional accreditation, by contributing to guidelines and standards, and actively interacting with the professional organizations and the policy makers. EuroGentest2 will also assist the diagnostic and clinical community and the individual laboratories and counseling units in reaching those aims by providing tools (e.g. a database of accredited laboratories, guidelines for quality procedures incl. validation, external quality assessment schemes, access to control materials, the systematic analysis of clinical utility of genetic tests) and the coordination of training (through the provision of quality-assured information and the organization of workshops, and through the validation of and training in novel methods and technologies). EuroGentest2 will further develop the work started by EuroGentest NoE, extending its activities from postnatal diagnostic and predictive testing to prenatal testing, including pre-implantation genetic diagnosis and noninvasive prenatal diagnosis, and to direct to consumer testing – which is timely for these rapidly evolving and partly controversial practices.

A major aim of the Coordination Action will be the creation of a European association of genetic diagnostic centres that will guarantee the future of the network.

The Coordination Action will lead to the further harmonization and quality assurance of genetic practice in Europe. The patients will benefit by the improvement of the analytical and clinical quality and validity of the testing, and from improved trans-border services and information. The European diagnostics industry will benefit through a faster access of innovations to the market through the validation for diagnostic use. It will enable countries and regions with less developed health care infrastructure to develop standards for best practice of provision of clinical genetic service. It will empower emerging economies in their efforts to build comprehensive health care service to integrate clinical genetics. The coordination action will also identify research needs, prioritise them and have the capacity to set a research agenda that corresponds to the needs of the human genetics community.

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Center for Human Genetics
University of Leuven
Herestraat 49 Box 602, 3000 Leuven, Belgium

Copyright EuroGentest2 Coordination Action 2011 - EU Contract no.: FP7 - HEALTH-F4-2010-261469